• 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

• 2022-02-18 08:16:14

Hong Kong's MDD has announced a few changes in the trial schemes on the acceptance of some reference agencies approval. MDD also announced the regularization of the expedited approval scheme for Class II/III/IV General Medical Devices.

• 2021-12-27 05:12:19

MDD announced the closing of the ongoing trial scheme for expedited approval of Class II/III/IV General Medical Device Listing Application on 31 December 2021. The limit application for applicants who wish to apply through the trial scheme have been lifted.

• 2020-08-11 05:46:22

The Medical Device Division (MDD) Hongkong will continue the trial scheme to simplified application and approval process of Class II/III/IV general medical device listing applications with established support on proven safety and performance.